Clinical trial · Interventional
A Phase II Study of Oxaliplatin in Association With 5FU and Folinic Acid in the Treatment of Subjects With Non-Surgical or Advanced Metastatic Gastric Cancer
NCT00611507CI-TRIAL-00001362completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This phase II trial will evaluate, in first line advanced or metastatic gastric cancer, the efficacy and tolerance of another oxaliplatin, 5FU bolus combination already tested in advanced colorectal cancer
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stomach Neoplasms | Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oxaliplatin, 5-Fluorouracil | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Response rate - RECIST criteria (unidimensional)
- timeFrame
- During the study conduct
Secondary outcomes (1)
- measure
- Progression-free Survival (PFS)
- timeFrame
- During the study conduct
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven gastric or gastroesophagic junction adenocarcinoma * Measurable disease at least in a unidimensional manner. If a unique metastasis constitutes the only disease symptom, histological confirmation will be required * Metastatic or locally non-surgical primary gastric cancer * Recurrent gastric cancer after local and/or systemic treatment with a post-surgical period of at least 4 weeks, a post-adjuvant chemotherapy period or a neo-adjuvant chemo-radiotherapy of at least 6 months * Serum bilirubin\< 2 mg/dl * Serum creatinine \< or =to 2 times normal superior limit * Absolute neutrophil count \> or =to 2000/dl * Platelet count \> or =to 100000/dl * Hemoglobin \> or =to 10 g/dl * AST/ALT \< or =to 2.5 times normal superior institutional limit * Alkaline phosphatase \< or =to 5 times the normal superior institutional limit * Age \> 18 years * Performance Status ECOG 0-2 * Written informed consent signed and dated Exclusion Criteria: * Symptomatic sensory peripheral neuropathy * Uncontrolled concomitant disease.(e.g. severe diabetes mellitus, arterial hypertension) * Any other malignancy diagnosed within 5 years previous to the gastric cancer, with the exception of " in situ " cervix carcinoma or non-melanoma skin cancer * Concomitant anti-tumoral treatment * Cerebral metastases * Unstable heart disease, even though under treatment * Myocardial infarction within the last 6 months * Pregnancy or nursing (or women in reproductive life without adequate contraception) * Significant neurological or psychiatric disorders
References
Publications (0)
Data not yet available
No reference posted for this study.